At a Glance
- Tasks: Manage projects to launch innovative therapies in the US and EU markets.
- Company: Join MoonLake, a dynamic biotech company revolutionising healthcare.
- Benefits: Flexible remote work, career growth, and a supportive learning environment.
- Other info: Collaborative culture with opportunities for professional development.
- Why this job: Make a real impact on global healthcare with groundbreaking projects.
- Qualifications: 5+ years in project management and biologics manufacturing experience.
As CMC Project Manager, you will provide your Project Management and CMC knowledge and expertise to support the Drug Substance (DS), Drug Product (DP) and Device teams and management of their vendors/suppliers through BLA, MAA and PAI processes to launch Sonelokimab in the US and EU markets.
Major Accountabilities:
- Work with DS, DP and Device team to ensure on-time, in-full and on budget delivery of internal project goals and milestones and key documentation for regulatory submissions.
- Work with external suppliers and vendors (alliance / account management) to ensure delivery of MoonLake’s project goals and milestones and key documentation for regulatory submissions.
- Support the Senior Director Project Management in ensuring adherence to the Moonlake governance structure and processes.
- Keep MoonLake Operational Plans (MOPs) up to date in SmartSheets and other PM tools as required through interactions with key business stakeholders and translate these into meeting materials / status reports / priority lists etc. for the different governance meetings.
- Assist in the arrangement and management of governance meeting agendas, slide decks, minutes etc.
- Champion and foster a culture change promoting and identifying cross functional interdependencies.
- Provide the Senior Director Project Management with project status updates, feedback, and appropriate reporting on the MoonLake Operation Plan.
- Evaluating risk on company projects and assist with identifying owners and mitigations.
- Use the MOP to assess KPIs, capacity and resourcing.
Experience:
- +5 years of experience in a PM / PMO environment
- +5-10 years DS or DP (biologics) manufacturing experience in a fast paced start-up or C(D)MO environment
Skills/knowledge/behavioural competencies:
- Strong project management skills in the areas of time, cost, quality and risk management
- Excellent written/verbal communication
- Prioritisation/organisation skills
- Ability to build relationships with stakeholders across multiple departments and geographies, internally and externally
- Negotiation and influencing skills
- Ability to scope, plan, execute, and track projects with autonomy, if assigned
- Excellent skills with Microsoft Word Office, Excel, PowerPoint, Outlook, Smartsheets etc.
- Identifying interdependencies and links for activities across functions not just within CMC
Work Location: 2 days a week in our brand new Cambridge Office(s)
Why us?
An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What we offer:
- Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
- Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
- Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
- Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values:
- We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
- We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
- We unlock value: We aspire to create long-term value for investors and communities.
About us: MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients. We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, with hubs in Cambridge.
Remote CMC Project Manager in Middlesbrough employer: MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is an exceptional employer, offering a dynamic and innovative work environment where passionate individuals can thrive. With a strong focus on employee growth, we provide opportunities for learning alongside experienced professionals while contributing to groundbreaking projects that aim to transform global healthcare. Our hybrid work model promotes a healthy work-life balance, ensuring that our team members can excel both personally and professionally in our brand new Cambridge office.
Contact Details:
MoonLake Immunotherapeutics Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Remote CMC Project Manager in Middlesbrough
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at MoonLake or similar companies. A friendly chat can sometimes lead to job opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching MoonLake’s projects and values. Show us you’re not just another candidate; demonstrate how your experience aligns with our mission to revolutionise healthcare.
✨Tip Number 3
Practice your pitch! Be ready to explain how your project management skills can help us meet our goals. Highlight your experience with DS and DP processes, and don’t forget to mention your knack for building relationships across teams.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re genuinely interested in being part of the MoonLake team.
We think you need these skills to ace Remote CMC Project Manager in Middlesbrough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the CMC Project Manager role. Highlight your project management experience and any relevant skills in drug substance or product manufacturing. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about joining MoonLake and how your experience can contribute to our mission. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills:Since this role involves a lot of collaboration, make sure to demonstrate your excellent written communication skills in your application. Whether it's through your CV, cover letter, or any additional documents, clarity and professionalism are key!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on being part of our team at MoonLake!
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC) processes. Be ready to discuss how your experience aligns with the Drug Substance and Drug Product teams, and how you can contribute to regulatory submissions.
✨Showcase Your Project Management Skills
Prepare examples that highlight your project management expertise, especially in time, cost, quality, and risk management. Use specific instances from your past roles to demonstrate how you've successfully managed projects and met deadlines.
✨Build Relationships, Even Virtually
Since this role involves working with various stakeholders, think about how you can showcase your relationship-building skills. Prepare to discuss how you've effectively collaborated with cross-functional teams and external vendors in previous positions.
✨Be Ready for Governance Discussions
Familiarise yourself with governance structures and processes. Be prepared to talk about how you've managed meeting agendas, slide decks, and minutes in the past, and how you can ensure smooth governance meetings at MoonLake.
